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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K930014
Device Name PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST
Applicant
VANGUARD BIOMEDICAL CORP.
10225 BARNES CANYON RD.,
SUITE A-108
SAN DIEGO,  CA  92121
Applicant Contact ROBERT SARGEANT
Correspondent
VANGUARD BIOMEDICAL CORP.
10225 BARNES CANYON RD.,
SUITE A-108
SAN DIEGO,  CA  92121
Correspondent Contact ROBERT SARGEANT
Regulation Number862.1155
Classification Product Code
JHI  
Date Received01/04/1993
Decision Date 03/25/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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